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Search for: Státní ústav pro kontrolu léčiv (SÚKL) uvádí na pravou míru mylné a zavádějící informace, které uvedla v článku „Kmenové buňky pro diabetiky: proplácení se odkládá“ redaktorka Lenka Petrášová.
Ways of submission of additional documents during Clinical Trial - 1%
26.02.2016 11:59:03State Institute for Drug Control, Clinical Trials Department informs about ways of submission of additional documents during Clinical Trial of human medicinal products.
Field Safety Corrective Actions in 2013 - 1%
3.01.2013 08:46:11Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
SUKL Bulletin - 1%
19.11.2007 10:24:33SUKL Bulletin has been published on a monthly basis by the State Institute for Drug Control in cooperation with Prof. Skarnitzl’s Foundation since 1994. It provides information on pharmaceuticals and on medical devices to healthcare professionals and pursuant to Act No 79/1997 Coll., on Pharmaceuticals, as amended, serves for the publication of issued decisions on marketing authorisations of medicinal products.
REG-59 version 1 - 1%
28.01.2009 11:23:15Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents
What is the difference between dietary supplements and over-the-counter medicinal products? - 1%
16.04.2010 14:14:50It is often difficult for the consumer to navigate in the deluge of products available in pharmacies as “over-the-counter” (OTC) products, and, in particular, distinguish the two basic types of these products – dietary supplements and medicinal products - with confidence.
Clinical trials on products containing genetically modified organisms - 1%
3.09.2004 15:53:04Instructions for applicants concerning requirements of the Czech Ministry of the Environment.
HOME CARE - 1%
13.05.2020 13:59:48Conditions under which it will be possible to include “ Home Care ” into the conduct of clinical trials also outside the period of COVID-19 pandemics.
Fees for Assessment of PART II of CT Applications Submitted via CTIS - 1%
20.12.2022 08:28:34Important notice for applicants for clinical trial authorisations submitted via CTIS (EU portal).
Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial - 1%
14.12.2017 10:29:05Clinical trial sponsors are kindly requested to send amendments to the protocol and updates to an approved/authorised clinical trial dossier in electronic format only.
Notice to applicants for placing of foreign language batch of a medicinal product on the market - 1%
30.10.2018 08:44:00Notice to applicants on requirements to permit the placing of foreign language batch of a medicinal product on the market in the Czech Republic.
Launch of the new Registry of Medical Devices - 1%
4.05.2015 14:20:59State Institute for Drug Control (SUKL), the Ministry of Health (Ministry of Health) and the Coordination Centre for Departmental Medical Information Systems (KSRZIS) inform the public about the launch of the public Registry of Medical Devices (RZPRO).
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